Regulatory Affairs Manager - In Vitro Diagnostics

  • Job Reference: 00004519-1
  • Date Posted: 14 May 2020
  • Recruiter: CV-Library
  • Location: Manchester
  • Salary: £50,000 to £65,000
  • Sector: Healthcare & Medical, Science & Technology, Covid-19
  • Job Type: Permanent

Job Description

We are currently supporting a multi-national and market leading business within the field of in-vitro diagnostics (IVD) to recruit a new Regulatory Affairs Manager to join their technical team.
The business:
With a big focus on product development in recent years and expanding into new markets, this is a great opportunity to play a key role as part of a wider team that are at the forefront of their industry for years to come. This is a business that are actively playing a role in combating Covid 19 and the global Coronavirus epidemic.
They have invested heavily into attracting and retaining highly skilled people across different functions within their company, so you'll be working with a team of very capable professionals.
The role and key responsibilities for the Regulatory Affairs Manager will involve:
The core of this role will be key to supporting the overall regulatory affairs strategy within the company to ensure they are working towards their wider company goals.
Key responsibilities will include:
* Leading a small RA team
* Managing and leading with IVDR planning transition within the company.
* Supporting post-market surveillance activity within the company.
* Responsible for leading, creating and maintaining technical files as well as preparing regulatory dossiers and maintenance of import/product licences.
* Communicating key regulatory information across the business and being a contact to stakeholders at all levels within the company on key regulatory/technical issues.
* Managing relationships with regulatory agencies
The ideal candidate for the Regulatory Affairs Manager will have the following background:
* Experience working as Regulatory Affairs Manager within the field of In-Vitro Diagnostics (IVD)
* Will have led small RA teams
* Good knowledge of IVD Regulations and Directives.
* Experience working with ISO 13485 standards.
* Degree or equivalent experience within life sciences field.
For more information, please contact Martin Ofosu at Radar Recruitment